Rectal Cancer
Conditions
Interventions
Group A (standard therapy group): UFT (400 mg/m2/day) is administered orally on days 1-5 of every week for 1 year.
Group B (trial therapy group): S-1 (80 mg/m2/day) is administered orally for 28 conse
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed rectal adenocarcinoma (exclude Rs) 2) Histological Stage IIA, IIB, IIIA, IIIB, IIIC located 3) No synchronous colorectal cancer which invade submucosa or deeper 4) Curative resection with lymph node dissection 5) Resection of histological curability A was performed 6) No prior therapy 7) Within 42 days after the operation 8) Oral intake is possible 9) Sufficient organ functions a. WBC >= 3,500/mm3 b. Hemoglobin >= 9g/dL c. Platelet >= 100,000/mm3 d. Total bilirubin <= 1.2mg/dL e. AST, ALT < 100IU/L f. Serum creatinine <= 1.0mg/dL 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Anal gland derived cancer of anal canal 2) Active synchronous or metachronous malignancy other than carcinoma in situ 3) Serious postoperative complications 4) Serious coexisting illness a. interstitial pneumonia, pulmonary fibrosis b. intestinal paralysis or obstruction c. uncontrolled diabetes mellitus d. hepatic cirrhosis e. hepatic failure f. renal failure g. uncontrolled hypertension h. history of myocardial infarction, unstable angina within 6 months prior to the registration 5) Limitation of use of UFT or TS-1 6) Under treatment with flucytosine, phenytoin, or warfarin 7) Episode of drug allergy reaching grade 3 or more severe 8) Pregnant or nursing 9) Severe mental disorders 10) Positive HIV 11) Not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse - free survival (RFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Adverse events | — |
Countries
Japan
Outcome results
None listed